Sunday May 27, 2012
The Regulation of Hazardous Substances in the U.S.By Patricia A. Hietter and Mark A. Kinzie
Several federal agencies regulate substances and materials in consumer, commercial, and industrial chemical products. Depending on the federal statute and the regulatory scheme, controlled and banned chemical substances are governed by multiple key regulations that identify individual hazardous substances or the product into which its ingredients are placed. Federal agencies also control chemicals by requiring labeling or testing of chemical substances and specific products before they enter the marketplace or are used in the workplace.
This paper identifies the federal authorities and accompanying statutes and regulations that govern their chemical products. The following Acts and regulations, to varying degrees, most commonly regulate chemical substances: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA), both of which are administered by the Environmental Protection Agency (EPA); the Consumer Product Safety Act (CPSA) and Consumer Product Safety Improvement Act (CPSIA), the Federal Hazardous Substances Act (FHSA), and the Poison Prevention Packaging Act of 1970 (PPPA), all of which are administered by the Consumer Product Safety Commission (CPSC); the Pipeline and Hazardous Materials Safety Administration (PHMSA) regulations; and the Occupational Safety and Health Administration (OSHA) regulations.
Much overlap exists among these various laws. The key to compliance is understanding the product and ingredient jurisdiction given each federal agency that administers these laws. This paper is a first look at how the makers of chemical goods can efficiently accomplish compliance across multiple regulatory bodies. See the How to Comply sections within each of the Key Regulations below.
(1) Federal Insecticide, Fungicide, and Rodenticide Act—FIFRA. FIFRA controls chemical substances in the form of active ingredients in pesticide products1. FIFRA broadly applies to any producer, defined as any person “who produces any pesticide, active ingredient, or device (including packaging, repacking, labeling, and relabeling). 2 Determining whether a product is a pesticide is a first step in discerning whether the product is required to be registered under FIFRA. Pesticide is defined as, “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant.3 If the chemical product meets this broad definition, the next step in determining whether a product is a pesticide is to consider intent (i.e., whether the product is intended for a pesticidal purpose).4 The regulations set forth criteria to determine if the required intent is established, including: whether there are claims or representations the product be used as a pesticide; whether the substance consists of active ingredients that have no other commercial purpose than as a pesticide; and whether the person who distributes or sells the substance has knowledge that the substance will be used for a pesticidal purpose.5 If any of these regulatory criteria are met, the manufacturer or processor can conclude that the product is a pesticide and is thus subject to the registration and labeling requirements.
Additionally, FIFRA-controlled chemical substances require product labeling, an ingredient statement, use classification, precautionary labeling (warnings to consumers), work protection labeling, directions for use, labeling claims, storage and disposal instructions, identification numbers, company name and address data, graphic symbols on the product label, and content and net weight statements. 6 These federal requirements tightly control FIFRA substances and their labeling.
How to Comply. Chemical manufacturers can comply with FIFRA requirements by identifying those substances that are regulated by the Act. Only chemical companies manufacturing or selling pesticide, rodenticide, or fungicides must comply with the accompanying regulations, or establishments that import those materials into the United States. These substances are not controlled by any other Act. Once a product is identified as a pesticide, rodenticide, or fungicide within the Act’s definition, a chemical manufacturer must ensure that the product is properly registered and licensed with the EPA and that the product’s labeling contains the detailed warnings that are tightly controlled by EPA regulations. Currently, only active ingredients must be identified on the product label with its percentage by weight, but the EPA is seeking to regulate inactive or inert ingredients by requiring disclosure on the label.
(2) Toxic Substances Control Act—TSCA. The TSCA provides the EPA with authority to require reporting, recordkeeping and testing requirements, and restrictions for controlled chemical substances. 7 Chemical substances regulated by the TSCA are “any organic or inorganic substances of a particular molecular identity including any combination of such substances occurring, in whole or in part, as a result of chemical reaction or occurring in nature and any element or uncombined radical.”8 The TSCA also addresses the production, importation, use and disposal of specific chemicals including polychlorinated biphenyls (PCBs), asbestos, radon, and lead-based paint.9
The TSCA characterizes and evaluates the risks posed by a chemical to humans and the environment before the chemical is introduced into commerce. The TSCA accomplishes this by requiring that manufacturers perform various kinds of health and environmental testing, use quality control in their production processes, and notify the EPA of information they gain on possible health effects from use of their products. 10 “Manufacturing” is defined to include “importing,” and thus all requirements applicable to manufacturers apply to importers as well.11 Entities that must comply with TSCA include manufacturers, importers, processors, distributors, and users of chemical substances. “Manufacture” and “process” indicate for commercial purposes. 12
The EPA has broad regulatory authority under TSCA to require labeling both for existing chemicals and for new chemicals on a case-by-case basis.13 At present, product labeling under TSCA is only required for asbestos, PCBs, hexavalent chromium, and acrylamide grout.14 The complete list of chemicals regulated through other means such as reporting, recordkeeping, and testing include: polychlorinated biphenyls (PCBs), asbestos, radon, lead-based paint, hexavalent chromium, acrylamide grout, phthalates, benzidine dyes, Bisphenol A (BPA), perfluorinated chemicals (PFCs), polybrominted diphenyl ethers (PBDEs), chlorinated parrafins, lead, mercury, formaldehyde, glymes, carbon nanotubes, and dibenzo-para-dioxins/dibenzofurans.15 Currently, there are no banned chemical substances under TSCA.
There is new legislation pending in Congress that would substantially change regulatory requirements for chemical manufacturers by broadening the EPA’s power under the TSCA. The Safe Chemicals Act of 2010 proposes safety testing of all industrial chemicals, and puts the burden on the industry to prove that chemicals are safe in order to remain on the market, among other requirements. Additionally, the EPA is expanding its control over toxic substances under the current TSCA, in part by establishing a “chemicals of concern” list that identifies hazardous chemicals and preparing action plans that will target the EPA’s risk management efforts regarding those chemicals.16
How to Comply. The TSCA governs industrial chemical substances. Only manufacturers and processors of commercial industrial products must comply with the health and environmental testing and recordkeeping required under the Act’s regulations, as household products containing hazardous ingredients are governed by the FHSA. A manufacturer must also ensure that their products are properly labeled if they are intended for commercial distribution and contain one of the following: asbestos, PCBs, hexavalent chromium, and acrylamide grout. With the TSCA in particular, chemical companies must stay abreast of new legislative reforms to the TSCA, and the new expanded authority given to the EPA over certain chemical substances.
(3) Federal Hazardous Substances Act—FHSA. The FHSA requires that certain household products containing hazardous substances contain cautionary labeling to alert consumers to potential product hazards and to inform them of the measures needed to protect themselves from those hazards.17 The FHSA is administered by the CPSC. Any product that is toxic, corrosive, flammable or combustible, an irritant, a strong sensitizer, or that generates pressure through decomposition, heat, or other means requires labeling, when the product may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonable foreseeable handling or use, including reasonable foreseeable ingestion by children. 18
The regulations issued under the FHSA specify the tests a manufacturer must perform to evaluate a product for the listed hazards of toxicity, corrosivity, flammability, or whether the product is an irritant, strong sensitizer, or capable of generating pressure through decomposition, heat or other means.19 There are no formal guidelines under the FHSA or its regulations to evaluate exposure to a product and its risk of injury. However, a manufacturer should consider: (1) how the contents and form of the product might cause an injury; (2) the product’s intended handling, use, and storage, and (3) any accidents that might foreseeably happen during handling, use, storage that could harm the purchaser, user, or others, including young children who might get into the package of the product. 20
The FHSA also gives the CPSC authority to ban the hazardous substance if it determines that the product is so hazardous that even cautionary labeling is inadequate to protect the public.21 The Commission has banned several products, including: extremely flammable water repellents for use on masonry walls and floors inside homes; carbon tetrachloride and mixtures containing it; various fireworks and firecrackers; liquid drain cleaners that contain 10% or more by weight of sodium or potassium hydroxide and that are not packaged in child-resistant packaging; products containing soluble cyanide salts; general use garments containing asbestos; self-pressurized products that contain vinyl chloride monomer as an ingredient or in the propellant; reloadable tube aerial shell fireworks devices that use shells wider than 1.75 inches; and any toy or other article that is intended for use by children and contains a substance that presents one of the hazards of toxicity, corrosivity, flammability, or if the product is an irritant, strong sensitizer, or capable of generating pressure through decomposition, heat or other means if a child can gain access to the substance.22
How to Comply. The FHSA is a labeling requirement. Further, only chemical manufacturers who produce household products containing hazardous substances must comply as the FHSA only applies to products that, during reasonably foreseeable purchase, storage, or use may be brought into or around a place where people live.23 In order to determine whether a product is hazardous, the chemical manufacturer must perform specific product testing as required by the regulations. If the product meets any of the hazard tests, the manufacturer must ensure that the product bears proper cautionary labeling before it enters the marketplace. In evaluating whether a product is hazardous, the manufacturer typically considers the finished product, rather than its individual ingredients.24
(4) Consumer Product Safety Act—CPSA. The CPSA designates jurisdiction of the Consumer Product Safety Commission (CPSC) over “consumer products” only. Consumer products are defined as “any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation or otherwise, or (ii) for personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise.25 The CPSA applies to manufacturers, retailers, and private labelers of consumer products.26 The more recent Consumer Product Safety Improvement Act of 2008 (“CPSIA”) broadly updated the existing CPSA on many levels, including the control of allowable thresholds for lead and phthalates.
The purpose of the CPSA is to protect the public against unreasonable risks of injury associated with consumer products, assist customers in evaluating the comparative safety of consumer products, develop uniform safety standards for consumer products, minimize conflicting state and local regulations, and promote research and investigation into the causes and prevention of product-related deaths, illnesses, and injuries.27
The CPSC has banned certain hazardous substances under the authority of the CPSA. Butyl nitrate is banned, which includes n-butyl nitrite, isobutyl nitrite, secondary butyl nitrite, tertiary butyl nitrite, and mixtures containing any of these chemicals, except if the product falls under limited exceptions under the Federal Food, Drug, and Cosmetic Act (FFDCA).28 Similarly, the CPSC has banned isopropyl nitrite and other nitrites, except for commercial purposes approved under the FFCDA.29 The regulations further ban a list of hazardous substances because, “they possess such a degree or nature of hazard that adequate cautionary labeling cannot be written and the public health and safety can only be served by keeping such articles out of interstate commerce.”30 This list includes mixtures that are intended primarily for application to interior masonry walls, floors, etc., as water repellant treatments that are extremely flammable and carbon tetrachloride and mixtures containing it, excluding certain minute manufacturing residues.31 Notably, the list also includes: liquid drain cleaners containing 10 percent or more by weight of sodium and/or potassium hydroxide and products containing soluble cyanide salts.32 Lastly, any self-pressurized products intended for household use that contain vinyl chloride monomer as an ingredient or in the propellant are deemed a banned substance under the regulations.33
The CPSC also regulates consumer products, mostly children’s products, under the new CPSIA and specifically requires that all manufacturers issue a General Conformity Certificate (GCC) for consumer products placed into commerce.34 Generally, household products containing chemical substances will require a GCC if any one of the following five (5) criteria applies: (1) the product contains a “hazardous substance” under the FHSA; (2) the product requires labeling under the FHSA; (3) the product requires special packaging under the PPPA; (4) the product is a pesticide regulated by FIFRA that requires special packaging under the PPPA; or (5) the product contains a substance regulated under the CPSA.35
How to Comply. Only chemical manufacturers of consumer products must comply with the CPSA and the CPSIA. The CPSA itself does not provide specific labeling requirements for chemical goods, with the exception of certain lead paint notifications and with regard to children’s toys, games, small parts, and child care articles. However, the CPSA regulations address labeling requirements for hazardous substances under the authority of the FSHA, also administered by the CPSC. Therefore, a chemical company must reference the FHSA’s labeling requirements if the product is hazardous as determined by the testing requirements under FHSA. Also, a chemical goods company that manufacturers or produces a consumer product that falls under CPSIA’s authority must understand when a GCC is required under the CPSIA, what must be included in the certification, how the certification may be distributed, and understand the consequences for failure to certify. In making this determination, a manufacturer should consult CPSIA regulations and guidance materials, as well as keep abreast of current industry trends regarding the issuance of a GCC.
(5) Poison Prevention Packaging Act of 1970—PPPA. The PPPA requires that special packaging be used to protect children from certain designated hazardous substances in household products also known as child resistant packaging.36 The purpose of the PPPA is to protect children from serious personal injury or illness resulting from the handling, using, or ingesting of hazardous substances in household products.37 Special packaging is defined as a “packaging that is designed or constructed to be significantly difficult for children under five (5) years of age to open or obtain a toxic or harmful amount of the substance… within a reasonable time and not difficult for normal adults to use properly.”38
Special packaging required under the PPPA must be tested before it is used to package the following products.39 Products which currently require special packaging are: furniture polish; liquid preparations containing more than 5% methyl salicylate; dry forms of household substances containing 2% or more unneutralized sodium and/or potassium hydroxide; household substances containing 10% or more turpentine; liquid kindling or illuminating preparations, such as cigarette lighter fuel, charcoal lighter fuel, camping equipment fuel, torch fuel, fuel for functional lanterns, each at 10% or more; household substances containing 4% or more sulfuric acid; anhydrous cholestyramine in powder form; household substances containing 10% or more ethylene glycol; prepackaged liquid solvents containing 10% or more benzene, toluene, xylene, petroleum distillates, kerosene, petroleum distillates, mineral seal oil, mineral spirits, naphtha, and Stoddard solvent; household glue removers containing more than 500mg acetonitrile; permanent wave neutralizers containing sodium bromated or potassium bromate; mouthwash; products containing more than 5.0 mg of lidocaine; products containing more than 0.5 mg of dibucain; products prepared for human use containing more than 250 mg naproxen; products prepared for human use containing more than 50 mg ketoprofen; household substances containing more than 50 mg fluoride; products prepared for human use containing more than 14 mg minoxidil; liquid household products containing more than 5% methacrylic acid; and any “hazardous substances” which is defined according to the FHSA.40
How to Comply. The PPPA directs its requirements to a manufacturer and packager of a chemical good, but provides no definition of either entity. Thus, it is recommended that a chemical goods company comply if they manufacture or handle chemical products that are to be distributed to households and that meets any definition of “hazardous” under the FHSA, or specifically enumerated in the list supra. Once it is determined that special packaging is required under the PPPA, the packaging must first be tested according to the regulations and then provided to the CPSC in the sizes and with the labeling to be used before it enters the marketplace.41 The CPSC provides detailed guidance about the compliance requirements for the PPPA.
(6) Pipeline and Hazardous Materials Safety Administration—the PHMSA regulations (“HazMat”). The Federal hazardous materials transportation law (Federal hazmat law) is governed by rules and regulations issued by the Pipeline and Hazardous Materials Safety Administration (PHMSA) within the DOT. These regulations protect against the risks to life, property, and the environment inherent in the transportation of hazardous materials in intrastate, interstate, and foreign commerce.42 Under its authority to enforce Federal hazmat law, PHMSA’s regulatory functions include issuing Hazardous Materials Regulations (HMR) that govern the safe transportation of hazardous materials by aircraft, railcar, vessel, and motor vehicle.43 HMRs cover: (1) hazardous materials classification; (2) packaging requirements; (3) hazard communication; (4) operational rules; (5) training and security; and (6) registration.
HMRs apply to persons who transport hazardous materials in commerce, offer hazardous materials for interstate, foreign, and intrastate transportation in commerce, and those persons who design, manufacture, fabricate, inspect, mark, maintain, recondition, repair, or test a package or container that is used in transporting hazardous material.44 Hazardous materials as defined under the HMR are found in Appendix A attached hereto. Notable exceptions include: petroleum, including crude oil, natural gas, natural gas liquids, liquefied natural gas, or synthetic gas useable for fuel (or mixtures of natural gas and synthetic gas).45 HMRs set forth the procedures and criteria for determining a hazard class for a specific material for controlled hazardous materials.46 Additionally, HMRs ban certain chemical materials from transport that are so hazardous that they cannot be transported safely.47
Under the HMRs, certain packaging is required as the first line of defense in ensuring that the hazardous material is not inadvertently released during transportation. Each package must be designed so that under conditions normally incident to transportation: (1) no identifiable release of hazardous materials to the environment occurs; (2) the effectiveness of the package is not substantially reduced during conditions incident to transport; (3) no mixture of gases or vapors in the package could, through any spontaneous increase of heat or pressure, significantly reduce the effectiveness of the packaging; and (4) no hazardous material residue adheres to the outside of the package during transport.48 Furthermore, the HazMat regulations require essential elements of hazard warnings are communicated through shipping documents and package markings and labels, among other means.49
How to Comply. A chemical goods manufacturer need only comply with federal Hazmat law if they offer quantities of hazardous materials for transport or if they participate in the manufacture or testing of packaging containers for those hazardous materials. Also, only certain hazardous materials are covered by the HMR. Thus, some chemical goods company may not be subject to PHMSA regulations if they typically manufacture household products or industrial products containing chemical substances that do not meet the specific requirements as defined by PHMSA regulations. However, if a chemical goods company falls under PHSMA regulation because of their specific functions or because they offer goods for transport in that meet reportable quantities, they must ensure that each package and label are designed for the specific hazardous material being transported. Additional regulatory requirements too detailed to mention here may be found within the PHMSA.
(7) Occupational Health and Safety Administration—the OSHA regulations. OSHA regulations, promulgated under the authority of the Occupational Safety and Health Act of 1970 (OSH Act),50 broadly cover industry and the protection of industry’s employees from hazardous materials and substances.51 Generally, certain hazardous substances and materials under OSHA’s control are regulated through precautionary labeling, packaging requirements, and employee training. Currently, OSHA regulates exposure to 400 substances discussed in Appendix B attached hereto. 52 OSHA’s Chemical Sampling Information (CSI) file contains listings for approximately 1,500 hazardous substances that also fall within OSHA’s scope of authority.
Specific hazardous materials also controlled by OSHA include: compressed gases; acetylene; hydrogen; oxygen; flammable and combustible liquids, including aerosols, and spray finishing using flammable and combustible materials. No chemical substances or materials are banned by OSHA. Lastly, chemical manufacturers need to be aware that twenty-four states have their own OSHA-approved state plans, standards, and enforcement policies.53 For the most part, these states have adopted standards that are identical to Federal OSHA, but some states have adopted different standards and enforcement policies of which chemical manufacturers must abide by for chemical substances in the workplace.
How to Comply. Chemical manufacturers must comply with OSHA regulations for chemicals found in their workplaces, or provided to the workplace, as the purpose of OSHA is to protect employees working with hazardous substances. Certain hazardous materials and substances are under OSHA’s control and are individually identified by OSHA regulations. Generally, companies must ensure that labeling, packaging requirements, and employee training for working with hazardous substances found in the workplace as called out by OSHA regulations are met to protect their employees from occupational exposure. OSHA is updating its regulatory requirements for MSDS documents, symbols, and language under the new Global Harmonization System of classification and Labeling (GHS) approved by the U.N.
1Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136. Inactive ingredients in pesticide products are currently being considered for regulation.
240 C.F.R. § 167.3.
340 C.F.R. § 152.3.
440 C.F.R. § 152.12.
540 C.F.R. § 152.15(a)-(c).
6Refer to the EPA Label Review Manual and FIFRA regulations at 40 C.F.R. §§ 150-189 to obtain specific guidance.
715 U.S.C. § 2601 et seq.
815 U.S.C. §2602(a).
915 U.S.C § 2601.
1140 C.F.R § 700.43.
12Commercial purpose is defined as, “to import, produce or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer, and includes, among other things, ‘manufacture’ or any amount of a chemical substance or mixture: (1) for commercial distribution, including for test marketing, or (2) for use by the manufacturer, including use for product research and development or as an intermediate. 40 C.F.R. § 710.2; 40 C.F.R. § 720.3.
1340 C.F.R. § 421.
14Refer TSCA regulations at 16 C.F.R. §§ 1301-1305 to obtain specific guidance regarding product labeling.
15Refer TSCA regulations at 16 C.F.R. §§ 1301-1305 to obtain specific guidance regarding requirements for these chemicals.
16Chemicals currently on the “chemicals of concern” list include:, phthalates, hexabromocyclododecane (HBCD), nonylphenol and nonylphenol ethoxylates, long-chain perfluorinated chemicals (PFCs), polybrominated diphenyl ethers (PBDEs) in products, short-chain chlorinated paraffins, Benzindine dyes and pigments, and Bisphenol A (BPA). Diisocyanates and siloxanes are in the action plan development process.
17The Federal Hazardous Substances Act, 15 U.S.C. §§ 1261-1278.
1816 C.F.R. § 1500.3.
19Refer FHSA regulations at 16 C.F.R. §§ 1500.40-1500.46 to obtain specific guidance.
20U.S. Consumer Product Safety Commission: Office of Compliance, Requirements Under the Federal Hazardous Substances Act: Labeling and Banning Requirements for Chemicals and Other Hazardous Substances (August 2002).
2216 C.F.R. § 1500.17.
23U.S. Consumer Product Safety Commission: Office of Compliance, Requirements Under the Federal Hazardous Substances Act: Labeling and Banning Requirements for Chemicals and Other Hazardous Substances (August 2002).
24U.S. Consumer Product Safety Commission: Office of Compliance, Requirements Under the Federal Hazardous Substances Act: Labeling and Banning Requirements for Chemicals and Other Hazardous Substances (August 2002).
2515 U.S.C. § 2053(a)(5).
26Consumer Product Safety Act, 15 U.S.C. §§ 2051-2089.
2715 U.S.C. § 2051(b)(1)-(4).
2815 U.S.C. § 2057(a).
2915 U.S.C. § 2057(b).
3016 C.F.R. § 1500.17(a).
3116 C.F.R § 1500.17(a)(1)-(2).
3216 C.F.R. § 1500.17(a)(4)-(5).
3316 C.F.R. § 1500.17(a)(10).
34The Consumer Product Safety Improvement Act of 2008.
3515 U.S.C. §2063(a)(1). Please refer to 74 FR 68328, 68330 (2008) for specific information regarding CPSC GCC requirements.
3616 C.F.R. § 1700.1.
3715 U.S.C. §1472(a)(1).
3815 U.S.C. § 1472(4).
39Refer to 16 C.F.R. § 1700.20 for specific guidance regarding testing procedures for special packaging.
4016 C.F.R. § 1700.14(a).
4116 C.F.R. § 1700.14(b); 16 C.F.R. §1700.20.
4249 U.S.C. § 5101 et seq.
43See, 49 C.F.R. §§ 171-180.
4549 C.F.R. § 173.1.
4649 C.F.R. 172.101.
48Refer to 49 C.F.R. § 173.24 for specific guidance regarding for special packaging required by Hazmat regulations.
49Refer to 49 C.F.R. § 172 for specific guidance regarding special hazardous communication requirements, including labeling, for hazardous packages.
5029 U.S.C. § 651 et seq.
5129 C.F.R. §§ 1910.101-119, 29 C.F.R. §§ 1910.1003-1096.
52See, 29 C.F.R. § 1910, Subpart Z.
53Alaska, Arizona, California, Connecticut, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virgin Islands, Virginia, Washington, and Wyoming. The Connecticut, Illinois, New Jersey, New York and Virgin Islands plans cover public sector employment only.